US FDA team arriving today; to sign deal on information sharing

A team of officials from the US Food and Drug Administration (FDA) will be arriving in India later today to assess the progress made by local authorities in ensuring quality of drugs, reports quoting sources in the Central Drugs Standard Control Organisation said.

Officials of the US regulator will meet their senior regulatory counterparts and industry leaders in India in order to enhance relationship building in the areas of medical products and food exported to the US.

Regulators of the two countries are expected to sign a memorandum of understanding on information sharing, training and such subjects, reports quoting official sources said.

The US team comprising justice department officials Howard Sklamberg (deputy commissioner for global regulatory operations and policy), Cynthia Schnedar (director of office of compliance of US FDA) and Michael R Taylor (deputy commissioner for foods and veterinary medicine of US FDA), is set to travel to New Delhi, Goa, Chennai and Mumbai.

The visit by US health officials is the second in just over a year after FDA Commissioner Margaret Hamburg visited India in February last year, following import alerts issued against all Ranbaxy plants in India, which effectively barred the company from the US market.

During Hamburg's visit last year, drug regulators of the two countries had signed a statement of intent on exchanging expertise to ensure higher levels of compliance, concerns of the regulators, training, adoption of systems and procedures and other areas.

The US FDA and the Indian regulator had also, last year, decided to meet on a regular basis, even as the FDA had offered to train Indian drug inspectors in the systems and processes used by the US regulator.

However, a year that has gone by seems to have not helped Indian drug manufacturers comply with US requirements and Indian pharmaceutical companies continue to receive warning letters from the US regulator.

Major manufacturers, including Sun Pharmaceuticals and Cadila Pharma are also under scrutiny by the US regulator since 2014.

Meanwhile, in a separate development, the US health regulator has inspected the Gagillapur manufacturing facility of Granules India, near Hyderabad, and did not find any deviation from good manufacturing norms.

''US-FDA had inspected Gagillapur facility last week and the inspection concluded with no observations,'' Granules India said in a BSE filing.

The inspection was triggered by one of the applicant's Abbreviated New Drug Application (ANDA) filing, it added.